FDA suggests more pricing regulations

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Statewide study finds huge profiteering in varied equipment at many levels; proposal sent to NPPA and health ministry to include these under National List of Essential Medicines now

After finding huge profiteering in margins for various surgical and nonsurgical equipment in its statewide study — ranging from 50 to 1,000 per cent — the Maharashtra Food and Drug Administration (FDA) is now attempting to introduce price control regulations for the devices in question.

The state FDA has submitted a report to the National Pharmaceutical Pricing Authority (NPPA) and Drugs Controller General of India (DGCI), asking that 24 more surgical and non-surgical instruments be included under the National List of Essential Medicines; the FDA also suggested that salts used in the manufacturing of several medicines be replaced with cheaper variants to cut prices. Recently, the NPPA had already capped prices of stents used in angioplasty procedures.

In its study, the FDA found alarming profiteering when it came to intraocular lenses, heart valves, balloon catheters, guiding catheters and all surgical equipment used in angioplasties. The entire chain from the manufacturer to the stockist, wholesaler, retailer and hospital was studied in this exercise.

Speaking to Mirror, FDA commissioner Pallavi Darade said, “We have sent our suggestions to the NPPA, and they have been forwarded to the ministry of health and family welfare for approval. The recommendation has been made specifically for surgical and non-surgical equipment that we found was commanding huge profit margins. We have further asked about catheters being found reused by several hospitals without informing patients, and demanded guidelines for the same.”

Reaffirming this, FDA joint commissioner Amrut Nikhade said, “We have sent several proposals for this price capping, all of which have undergone primary scrutiny by NPPA and been referred to the ministry. After approval, the suggested equipment will be added to the National List of Essential Medicines and their final prices decided. There is a huge difference in the actual manufacturing price and that being charged to patients at the moment.”

Weighing on this decision, Ruby Hall Clinic chief cardiologist and Cardiological Society of India former president Dr Shirish (MS) Hiremath said, “The NPPA has already capped prices for stents, thus decreasing the cost of angioplasties. But, the prices of balloon catheters, guiding catheters and other surgical equipment have been the same for a long time. Even if they are capped, angioplasty surgery costs may decrease just slightly — the difference will not be much.”

Vicky Pathar, ET
https://health.economictimes.indiatimes.com/news/medical-devices/fda-suggests-more-pricing-regulations/63329484

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